Drug ban row continues as Delhi High Court extends stay

Justice RS Endlaw asked the companies to provide a list of the drugs for which they were issued licenses by state licensing authorities (SLAs) and those for which Drug Controller General of India (DCGI) had given them approval.Prabha Raghavan | ET Bureau | March 29, 2016, 12:46 IST

New Delhi: The Delhi High Court on Monday yet again extended the stay on the government’s ban of brands using certain fixed dose combination (FDC) drugs by one day, and told petitioning companies to separately list drugs for which the central drug regulator had given them approval.

Justice RS Endlaw, while extending the stay on ban of several popular FDC brands, asked the companies to provide a list of the drugs for which were issued licenses by state licensing authorities (SLAs) and those for which Drug Controller General of India (DCGI) had given them approval.

The high court extended the stay last granted on March 21 as it went through nearly 100 petitions. On Monday, Endlaw was in the process of hearing arguments of the government and over 35 pharmaceutical companies.

Petitioners and the government exchanged barbs over legalities of the ban and safety concerns with these combinations.

Counsels of petitioning companies argued that, apart from refusing to involve companies in proper discussions over the safety and efficacy of the FDCs before implementing the ban, the government had also banned FDCs for which they had received DCGI approval.

“There is no reason given why several drugs approved by DCGI have been banned. The expert committee report itself in several cases says that (some of these FDCs) have been approved by the Centre, so (they are) not considering it,” said a lawyer representing one of the petitioning companies.

The expert committee report, which the government made public on March 22, also does not show how there is no therapeutic justification for the ingredients involved in these combinations, argued the lawyer.

The government had begun the exercise of weeding out “irrational” FDCs through a public notice calling for companies to submit only SLA licensed FDC products for evaluation, a health ministry official earlier told ET.

Some lawyers representing petitioners argued that the government had also not consulted the Drug Technical Advisory Board (DTAB)—the statutory committee provided under the Drugs & Cosmetics Act—before banning these FDCs.

According to the government, these arguments are secondary to the issue that these drugs have been found to be unsafe for consumption.

“This ban is not related to any specific licence, manufacturer or brand. This exercise was started pursuant to a report by the parliamentary standing committee,” said Sanjay Jain, additional solicitor general (Delhi High Court). "These FDCs are not safe or efficacious for human consumption and there is no justification or rationale for them,” he added.

The banned combinations were never given international approval and have enough single drug alternatives that are even manufactured by some of the petitioners, according to Jain. “No patient is going to die without these FDCs because they are independently available,” he said.

The companies that petitioned after Pfizer have received a stay order on the basis of parity and not on merit, according to the government.

There will now be a day-to-day hearing for these cases, Jain said. The court will also decide whether there is legal justification of granting the stay on Tuesday, he added.